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Akt/ERK Inhibitor

ONC201 + Paclitaxel for Ovarian Cancer

Phase 2

Recruiting

Led By Ira Winer, M.D.

Research Sponsored by Ira Winer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1

Histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer

Must not have

Major surgical procedures ≤21 days of beginning study treatment, or minor surgical procedures ≤7 days. No waiting required following port-a-cath placement, ureteral stent placement, percutaneous nephrostomy tube placement

No other (chemotherapy, immunotherapy, hormonal anti-cancer therapy, radiotherapy [except for palliative local radiotherapy]), biological therapy or other novel agent is to be permitted while the patient is receiving study medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a combination of two drugs, ONC201 and paclitaxel, to see if they are effective in treating ovarian, fallopian tube, or primary peritoneal cancer that has returned or stopped responding to other treatments.

Who is the study for?

This trial is for women with certain types of ovarian, fallopian tube, or primary peritoneal cancer that's resistant to platinum-based chemotherapy. Participants should have at least one measurable lesion and be in good physical condition (ECOG score 0-1). They must not be pregnant or breastfeeding, agree to use contraception, and have adequate organ function. Those with more than four prior treatments in the resistant setting or a total of seven overall are excluded.

What is being tested?

The trial is testing ONC201 combined with weekly paclitaxel against these cancers. ONC201 targets specific receptors on cancer cells while paclitaxel stops their growth by various means. The study aims to see if this combination works better than paclitaxel alone for patients who haven't responded well to previous platinum-based therapies.

What are the potential side effects?

Possible side effects include allergic reactions to treatment components, fatigue from chemotherapy drugs like paclitaxel, potential liver or kidney issues due to drug processing demands on these organs, blood disorders resulting from bone marrow suppression by chemotherapy agents, and gastrointestinal symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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I have been diagnosed with cancer in my ovary, fallopian tube, or the lining of my abdomen.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had major surgery in the last 3 weeks or minor surgery in the last week.

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I am not on any other cancer treatments while on the study medication.

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I haven't taken drugs or products like grapefruit juice that affect certain liver enzymes recently.

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My brain metastases are stable and I haven't taken steroids for them in the last 14 days.

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I cannot swallow pills.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of dose limiting toxicities (DLT's) (Part 1)

Incidence of treatment related adverse events (AEs) (Part 1)

Objective response rate (ORR) (Part 2)

+1 more

Secondary study objectives

CA-125 response rate

Disease clinical response (DCR)

Duration of response (DOR)

+6 more

Other study objectives

Cytokine profile

NK cell evaluation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment - ONC201 & PaclitaxelExperimental Treatment3 Interventions

Patients receive ONC201 PO on days 1, 8, 15, and 22 and paclitaxel IV over 1 hour on days 2, 9, and 16. Cycles repeat every 28 days in the absence disease progression or unacceptable toxicity. If paclitaxel must be stopped for any reason, patients may continue on ONC201 alone.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5450

0 / 7Eligibility criteria met